After completing this hands-on, interactive workshop:
- All participants will be able to plan, conduct and document an audit of excipient manufacturing facilities for conformance to excipient GMP expectations.
- Excipient makers will be able to assess their conformance to NSF/IPEC/ANSI 363 and remediate any gaps.
- Excipient users will be able to:
- assess their suppliers for adequate conformance to NSF/IPEC/ANSI 363.
- address the EU Falsified Medicines Directive (FMD) Guideline on the formalized risk assessment for determining the appropriate good manufacturing practice for excipients of medicinal products for human use.
"Excellent training. Mock audits were helpful and applicable to all different types of excipient suppliers. I found the topic on where excipient (GMP) starts very insightful"
"After this course, I have more confidence to host customer (user) audits and understand where citing non-conformances may come from"
"Great course for benchmarking skills and auditor attitudes"